At a Glance
- Tasks: Lead quality initiatives and ensure compliance across UK/IE and Nordics pharmaceutical operations.
- Company: Join a global leader in the pharmaceutical industry focused on innovation and quality.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Other info: Dynamic role with leadership opportunities and a focus on continuous improvement.
- Why this job: Make a significant impact on healthcare by ensuring high-quality standards and compliance.
- Qualifications: 15+ years in pharma quality assurance with strong regulatory knowledge required.
The predicted salary is between 80000 - 127600 £ per year.
About the role: As a core member of the Region Europe / CAN Commercial Quality Leadership Team, you provide leadership, guidance and lead a network of Cluster UK/IE and Nordics Quality Leaders across Local Operating Companies (LOCs), while also implementing it for the LOC you lead (UK/IE) in your dual role as LOC CQ Head UK/IE. This Cluster of LOCs has high complexity and/or have major global business impact requiring strong quality governance, compliance focus and precise execution. You will ensure robust GxP compliance, inspection readiness, and continuous improvement while enabling business growth and transformation.
Partnering closely with regional and global Quality leaders - and cross functional stakeholders such as Commercial, Supply Chain, Pharmacovigilance, Medical, and Regulatory Affairs—you will align local strategies with Takeda’s Global Quality strategic pillars and the CQ Strategy. You serve as the Global Quality point of contact with key Commercial Leaders continuously seek efficiencies and innovative approaches to improve processes and outcomes. Provide leadership, guidance drive innovative change and support business transformation.
Manage GxP regulated activities in partnership with the Regional CQ Leaders, including in country distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing/packaging/analytical testing quality oversight, and in country clinical and medical device activities; serve as strategic quality business partner and maintain strong relationships with Commercial, Supply Chain, Pharmacovigilance, Medical, and Regulatory Affairs.
Implement Supplier Quality Program in the LOCs using a lifecycle management approach for local GxP suppliers (includes selection and qualification, Quality Agreements, and oversight). Ensure there is quality oversight of local GCP/GVP/Devices/Medical related activities under CQ responsibility. Lead or support timely Health Authority communications on product quality and compliance issues, ensuring proper execution within the cluster by the appropriate CQ Lead, and drive resolution and escalation of product quality and compliance issues affecting LOCs across the Cluster.
Lead regulatory surveillance and intelligence in the LOCs for new or emerging regulations and ensure coverage and response across the cluster. Provide guidance and support inspection readiness of LOCs in the cluster to maintain a favorable regulatory profile with Heath Authorities. Partner with GPP and Cluster/local stakeholders to operationalize Global Product Protection strategies within the Cluster/LOC ensuring supply chain integrity and embedding product protection into the quality system.
Ensure self-inspections are performed to monitor compliance with applicable procedures and requirements. Drive quality capability-building and improvement programs across the Cluster, including quality risk management, compliance education, and digital quality initiatives, to enhance quality decision-making and operational excellence. Lead cluster-wide quality transformation initiatives to strengthen sustainability, compliance with Takeda QMS and local regulatory requirements, and embed a strong quality culture across LOCs through continuous improvement and best-practice adoption.
Ensure compliance with the below regulations / requirements. Works closely with the Quality Team and key personnel across relevant functional areas to ensure that responsibilities pertaining to the scope of the Wholesale Distribution Authorisations and Market Authorisations held by Takeda UKIE MCO legal entities (TUK and TPIL) are fulfilled.
- European Union EU Directive 2001/83/EC on the Community code relating to medicinal products for human use;
- EU Wholesale Distribution of Medicinal Products for Human Use of EU Directive 2001/83/EC as amended
- EU Directive 2011/62/EU on Falsified Medicines;
- EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01);
- EU Good Pharmacovigilance Practices (GVP, EudraLex Volume 9).
United Kingdom:
- The Human Medicines Regulations 2012, UK Statutory Instruments 2012 No. 1916;
- The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 S.I. 2019/62;
- Misuse of Drugs Act 1971;
- The Misuse of Drugs Regulations 2001;
- MHRA Guidance on Pharmacovigilance procedures.
Republic of Ireland:
- Medicinal Products (control of wholesale distribution) Regulations 2007 S.I. No. 538 of 2007;
- Ireland Misuse of Drugs Regulations 2017 (S.I. No. 173 of 2017).
Minimum Requirements/Qualifications: Scientific degree (BSc, MSc) in Pharmacy, Life Sciences, Engineering, or related field (or equivalent experience). At least 15 years of increasing management responsibility in the pharmaceutical industry including Quality Assurance, combined with a strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region. In-depth knowledge of global pharmaceutical operations, supply chain / distribution management, CMO management, Quality. Proven track record to lead strong influence and stakeholder management skills. Data and digital fluency (e.g., metrics, dashboards, analytics, automation) to enhance decision making and efficiency. Fluent in written and spoken English.
Locations: London, Great Britain
Base Salary Range: £92,800.00 - £127,600.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
For information about our benefits, please click here.
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Cluster Quality Head, UK/IE + Nordics, CQ employer: Takeda Pharmaceuticals
At Takeda, we pride ourselves on being a global top employer that champions diversity, equity, and inclusion within a dynamic and purpose-driven environment. Located in the vibrant city of London, our employees benefit from exciting career paths, a collaborative work culture, and opportunities for personal and professional growth, all while contributing to our mission of improving people's health worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Cluster Quality Head, UK/IE + Nordics, CQ
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Takeda Pharmaceuticals. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Takeda Pharmaceuticals.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Takeda Pharmaceuticals. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Takeda Pharmaceuticals is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Cluster Quality Head, UK/IE + Nordics, CQ
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Takeda Pharmaceuticals!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Takeda Pharmaceuticals that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Takeda Pharmaceuticals!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Takeda Pharmaceuticals, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Takeda Pharmaceuticals
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Takeda Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Takeda Pharmaceuticals’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
